Control of the Last Mile to ensure end-to-end compliance and protection of our products. Maurizio Caschera QA Manager

Transcription

1 Control of the Last Mile to ensure end-to-end compliance and protection of our products Maurizio Caschera QA Manager Arena International Cannes /02/2015 1

2 CO00993(1) Sanofi Pasteur MSD SNC au capital de euros - RCS LYON B January 2015 SANOFI PASTEUR MSD Vaccines for Life 2

3 A unique joint venture focused exclusively on vaccines Sanofi Pasteur 50 % R&D Manufacturing R&D Manufacturing Merck Vaccines 50 % Epidemiology Clinical Development (from phase III) Regulatory Affairs Pharmacovigilance CREATED IN 1994 Distribution Commercialisation Supply Communication Quality Assurance Medical Affairs Marketing Health Policy Market Access 3

4 A strong vaccine heritage at the service of vaccine prevention Louis Pasteur a pioneer who revolutionised modern medicine by administering the first anti-rabies vaccine in In the 1860 s, he demonstrated that infections were caused by microorganisms. In 1885, Louis Pasteur made the discovery of the rabies vaccine. George Merck largely contributed to the research and development of vaccines, starting from the 1950 s. Maurice Hilleman developed, in the 1960 s, numerous vaccinations including the vaccines against measles, mumps, and chicken pox. The Mérieux family led a bio-industrial venture that impacted the course of vaccination thanks to the large-scale production of vaccines. One of Pasteur s students, Marcel Mérieux created the Mérieux Institute in 1897, which was passed on to his son, Charles, and grandson, Alain. They dedicated their lives to the development and industrial manufacturing of vaccines with the ambitious goal to vaccinate all of the children in the world. Jonas Salk invented the first inactivated virus against poliomyelitis, in Creation of Sanofi Pasteur MSD in 1994 A European joint venture between Sanofi Pasteur (vaccine division of Sanofi) and Merck vaccines (known as MSD). 4

5 Sanofi Pasteur MSD at a glance 1 More than 1,000 professionals dedicated to vaccines Present in 19 countries across Europe European leader with roughly 80 million vaccine doses distributed per year Broadest range of vaccines in Europe protection against over 20 infectious diseases Vaccines for all age groups from infants to the elderly Sanofi Pasteur MSD Headquarters, Lyon France 1. Sanofi pasteur MSD internal data 5

6 VACCINES FOR LIFE Sanofi Pasteur MSD more information on spmsd.com 6

7 Topics of the presentation Why supply chains sometimes fail at the last mile? Some case studies A possible solution: closing the gap in information transfer with all stakeholders including last mile drivers Understanding your customer s capabilities so that you deliver the IMP and they will be successfully managed in the required conditions Conclusions 7

8 Topics of the presentation Why supply chains sometimes fail at the last mile? Some case studies A possible solution: closing the gap in information transfer with all stakeholders including last mile drivers Understanding your customer s capabilities so that you deliver the IMP and they will be successfully managed in the required conditions Conclusions 8

9 Why supply chains sometimes fail at the last mile? Some case studies As last mile we define the last step of the supply chain where there are several deliveries concentrated in a limited area. In this situation we have a complex distribution scenario with two different typologies of issues: 1) Issues registered during the last step of the transport from the transit point to the customer 2) Issues registered at the delivery at customer level: claims from the customer 9

10 Why supply chains sometimes fail at the last mile? Some case studies Issues registered during the last step of the transport, from the transit point to the customer. Main causes 1) The customers fragmentations means many possible stops before to arrive to the specific customer. As a consequences we may have many possibility of temperature deviations. The risk to have these Temperature deviations depends on: the time needed to perform each single products delivery (time for truck downloading) the truck validation or qualification the external temperature and the Customer delivery area 10

11 Why supply chains sometimes fail at the last mile? Some case studies Issues registered during the last step of the transport, from the transit point to the customer. Case Study 1: Delivery performed in the South of Italy in October. One customer refuses goods because of some previous cold chain deviations due to trucks door opening. The courier made available all the Temperature registration with calibrated T devices. Maximum Temperature reached is 9.7 C. If the delivery is in a hospital area, the truck motor engine has to be turned off. These can be considered as physiological cold chain deviations due to several stops. Possible solution: an improvement of the equipment, engine of the refrigeration independent from the truck engine. 11

12 Why supply chains sometimes fail at the last mile? Some case studies Issues registered during the last step of the transport, from the transit point to the customer. Main causes 2) Limited choice of local Couriers, an high level of quality is not possible; As a consequences we may these possible issues: Trucks breakage; Deliveries out of agreed delivery times range and risks of goods refusal; Wrong products/quantity delivered with cases of returned goods evaluations; Loss of products at Courier level. According to the 2011/62 EC provisions, measures have to be taken in order to avoid the return in the distribution channel of "falsified" medicinal product. 12

13 Why supply chains sometimes fail at the last mile? Some case studies Issues registered during the last step of the transport, from the transit point to the customer. Case Study 2: A shipment with 2 standard boxes was sent to a Customer. One box was temporary lost in a Courier transit point. If, by case, there are no identification codes on the boxes allowing us to understand which product is lost and which product is traced, we have these issues: - Difficulty to perform a partial delivery to the Customer because we are not sure about what is delivered. - The temporary loss of the box has to investigated and, even if the box will be found, it will be destroyed. - The box traced has to be returned to the warehouse => possible returned goods evaluation 13

14 Why supply chains sometimes fail at the last mile? Some case studies Issues registered at the delivery at customer level: Claims from the customer Local Couriers not always aware about "Good deliveries practices" at Customer level. This may cause, as consequences, claims from Customers coming from: Temperature checking by the Customers at the arrival: - Delivery time not always reported - Customers Temperature devices not always calibrated (different tools used, not only thermometers ) Products downloading operations (operations not performed at the presence of the Customer Responsible Person, delivery documents not completely signed, customer fridges not immediately available ) 14

15 Why supply chains sometimes fail at the last mile? Some case studies Case Study 3: A delivery is refused by the Customer because the temperature was monitored after the doors opening in the downloading operation and it is more than 8 C. The goods were then temporary placed by the Customer outside the cold room. There was no indication about the time of delivered in the shipping documentation and there was no signature. Therefore when the Customer RP came to the delivery point found them out of the cold chain. The shipment was refused. This is a case where apparently there was no cold chain deviation at Courier level but there is a total lack of training from the Courier... 15

16 Topics of the presentation Why supply chains sometimes fail at the last mile? Some case studies A possible solution: closing the gap in information transfer with all stakeholders including last mile drivers Understanding your customer s capabilities so that you deliver the IMP and they will be successfully managed in the required conditions Conclusions 16

17 A possible solution: closing the gap in information transfer with all stakeholders including last mile drivers A possible common solution to all these issues can be: to make independent the delivery operation from all the external concomitant conditions. This means to standardize the processes with: - Quality Technical Agreement established between the different distributors actors (warehouse, couriers, wholesaler, each one according to his responsibilities) based on GDP requirements and Company & Products requirements - Accurate audits for all the distribution actors requiring the same level of quality as indicated in the Quality Technical Agreement - Accurate and dedicated operative trainings for all the distribution actors 17

18 A possible solution: closing the gap in information transfer with all stakeholders including last mile drivers - Shipments traceability: Technological Solutions to trace each shipment in order to know in real time where is it - Continue Temperature monitoring and traceability: this is possible using trucks validated or/and transit points with cold room qualified or isothermal boxes qualified 18

19 Topics of the presentation Why supply chains sometimes fail at the last mile? Some case studies A possible solution: closing the gap in information transfer with all stakeholders including last mile drivers Understanding your customer s capabilities so that you deliver the IMP and they will be successfully managed in the required conditions Conclusions 19

20 Understanding your customer s capabilities so that you deliver the IMP and they will be successfully managed in the required conditions In the case of IMP transport, as Pharma Company, we are not only responsible for the delivery to the Customer, our responsibility is also ensuring a conform IMP management after the delivery customer until the product administration in order to not affect the quality of the Clinical Trial. We should ensure that doses are correctly stored and managed, firstly, in the storage location and, later, in the transport from the storage location to the vaccination site. This scope can be achieved by different steps: 20

21 Understanding your customer s capabilities so that you deliver the IMP and they will be successfully managed in the required conditions 1. Understand the Customer As Is situation: Audit to the investigation site in order to achieve the following info: - Average time from the truck delivery to the storage in the Pharmacy - Quality of T monitoring at the pharmacy refrigerator - Quality of cold chain deviation reporting - Storage capacity at the Pharmacy and at the Vaccination Site; - Info on the transport from the pharmacy to the vaccination site (duration of the transportation, way of transportation, controls in place during the transport); 21

22 Understanding your customer s capabilities so that you deliver the IMP and they will be successfully managed in the required conditions 2. Stating these data we can assess the investigation site and map possible quality gaps. On the base of the study needs, GDP requirements, local constraints, local processes "ad hoc" can be structured, KPIs assigned and training done in order to improve the quality of the storage/distribution activities at the investigation Site. 22

23 Topics of the presentation Why supply chains sometimes fail at the last mile? Some case studies A possible solution: closing the gap in information transfer with all stakeholders including last mile drivers Understanding your customer s capabilities so that you deliver the IMP and they will be successfully managed in the required conditions Conclusions 23

24 Conclusions - Last mile transportations are shipment where you have several local constraints and several customer stops - Last mile is also the step of the distribution more visible for the Customer. - A Customer claim for shipment not conform (issues on Temperature monitoring or product traceability or product typology/quantity ) has not only consequences on the possibility to use the products or not but has an impact on the Company image. - The only possibility way to manage this complex distribution scenario is to have robust and standardized processes and perfectly shared with our distribution partners - These processes that can be slightly customized to local constraints. 24

25 Thank You Maurizio Caschera Quality Assurance Manager Sanofi Pasteur MSD SpA